{"entity":{"id":"mesoblast","kind":"company","name":"Mesoblast","aka":["Mesoblast, Inc.","Mesoblast Limited"],"tldr":"Mesoblast is an Australian cell therapy company whose remestemcel-L became in December 2024 the first mesenchymal stromal cell therapy approved by the FDA, for children with steroid-refractory acute graft-versus-host disease.","summary":"Mesoblast, headquartered in Melbourne with a US base in New York, develops allogeneic mesenchymal stromal cell therapies from healthy donor bone marrow. After a long regulatory path including an earlier complete response letter, its product remestemcel-L (Ryoncil) was approved by the FDA in December 2024 for steroid-refractory acute graft-versus-host disease in children aged two months and older, a complication of stem cell transplantation for blood cancers. The company is also developing the platform for heart failure and back pain. Company facts are from FDA approval records.","asOf":"2026-09-11","wikipedia":"https://en.wikipedia.org/wiki/Mesoblast","links":[{"label":"FDA approval announcement for remestemcel-L","url":"https://www.fda.gov/news-events/press-announcements/fda-approves-first-mesenchymal-stromal-cell-therapy-treat-steroid-refractory-acute-graft-versus-host"}],"tags":["fda-oce-applicant"],"related":[],"cancers":[],"sections":["cell-therapy","supportive-care"],"technologies":[],"targets":[],"drugs":["remestemcel-l"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"provenance":{"editedBy":"OnCo ingestion (ClinicalTrials.gov v2 + sponsor websites)","editedOn":"2026-09-11"},"hq":"Melbourne","country":"AU","companyType":"cell-therapy","website":"https://www.mesoblast.com","stage":"public","investors":[],"funding":[]},"route":"/companies/mesoblast/","neighbours":{"section":[{"id":"cell-therapy","kind":"section","name":"Cell Therapy","route":"/fronts/cell-therapy/"},{"id":"supportive-care","kind":"section","name":"Supportive Care & Survivorship","route":"/fronts/supportive-care/"}],"drug":[{"id":"remestemcel-l","kind":"drug","name":"Remestemcel-L","route":"/drugs/remestemcel-l/"}],"trial":[{"id":"msb-gvhd001","kind":"trial","name":"MSB-GVHD001","route":"/trials/msb-gvhd001/"}],"paper":[{"id":"paper-msb-gvhd001-bbmt-2020","kind":"paper","name":"A phase 3, single-arm, prospective study of remestemcel-L, ex vivo culture-expanded adult human mesenchymal stromal cells for the treatment of pediatric patients who failed to respond to steroid treatment for acute graft-versus-host disease","route":"/key-papers/paper-msb-gvhd001-bbmt-2020/"}]}}